Study on DS-1062a for Advanced or Metastatic Non-small Cell Lung Cancer with Specific Genetic Changes

Sponsor: Daiichi Sankyo

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04484142

Provider View

This clinical trial is testing a new drug, DS-1062a, to see if it is safe and effective for treating advanced or metastatic non-small cell lung cancer (NSCLC) in patients with certain genetic changes. Participants must have previously received specific treatments for their cancer.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness, safety, and how the body processes the drug DS-1062a in patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has specific genetic changes. Participants must have already been treated with a platinum-based chemotherapy and at least one targeted therapy. The study includes three phases: screening, treatment, and follow-up. Researchers will analyze how well the cancer responds to the treatment after participants have been in the study for at least nine months or have stopped participating.

Description

This clinical trial is investigating the drug DS-1062a at a dose of 6.0 mg/kg in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have specific genetic changes. Participants must have previously received one platinum-based chemotherapy and one or more targeted therapies. The study is divided into three parts: Screening, Treatment, and Follow-up. The main goal is to measure the Objective Response Rate (ORR) to the treatment, which will be reviewed by an independent team after participants have been in the study for at least nine months or have left the study.

Eligibility Criteria

Inclusion Criteria

  • Must sign a consent form before starting any study-related procedures.
  • Adults aged 18 years or older.
  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) at stage IIIB, IIIC, or IV.
  • Have specific genetic changes in the cancer, such as EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
  • Must have experienced disease progression after previous treatment for advanced or metastatic NSCLC.
  • Must have been treated with at least one platinum-based chemotherapy and up to two other chemotherapy treatments.
  • May have received one checkpoint inhibitor treatment.
  • Must have received targeted therapy for the specific genetic changes in the cancer.
  • Must provide a tumor sample for testing.
  • Must have measurable disease based on imaging tests.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have untreated or active brain metastases or spinal cord compression.
  • Have leptomeningeal carcinomatosis (cancer spread to the membranes surrounding the brain and spinal cord).
  • Have previously been treated with certain types of chemotherapy or targeted therapies.
  • Have uncontrolled or serious heart disease, such as recent heart attack, severe heart failure, or uncontrolled high blood pressure.
  • Have a history of lung disease that required steroid treatment or current lung disease.
  • Have severe lung problems from other illnesses.
  • Have significant eye disease affecting the cornea.
  • Have other active cancers, except for certain skin cancers or other cancers that have been treated and have shown no signs of disease for at least three years.

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